Detailed Action
The present office action is in response to the amendments filed on 04 Dec 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status
Claims 3-10 and 13-18 of the pending application have been examined on the merits. Claim 12 remains withdrawn and claims 19-20 are newly withdrawn (see “Response to Applicant Remarks” below). Acknowledgement is made of the amendments filed on 04 Dec 2025. Acknowledgment is made of the cancellation of claims 1-2 and 11.
Priority
The instant App. No. 17/773,425, filed 29 Apr 2022, is a National Stage Entry of International App. No. PCT/US2020/058081, filed 30 Oct 2020, which claims priority of Provisional App. No. 62/929,299, filed 01 Nov 2019.
Response to Applicant Remarks
Applicant’s remarks filed 04 Dec 2025 are acknowledged.
Newly added claims 19-20 are withdrawn as not being directed to the elected group.
The objections to claims 1-2 are rendered moot following applicant amendments.
The rejections of claims 1-2 are rendered moot following applicant amendments.
The rejection of claim 5 under 35 U.S.C. § 102 is rendered moot following applicant amendments.
The rejection of claims 3 and 7-8 under 35 U.S.C. § 112(b) have not been overcome by applicant amendments. These rejections are maintained and restated below.
The rejection of claims 3-4 and 10 under 35 U.S.C. § 102(a)(1) over WO 2010/101128 (provided in the office action mailed 29 Sep 2025), hereinafter ‘128, has been overcome in part and remains in part following applicant amendments. The rejection has therefore been amended to only recite the parts of ‘128 which anticipate the instant claims.
Claim Interpretation
The compounds of the instant application have a pyrazole core, which exhibits tautomerization as exemplified by Secrieru et al. (Molecules, 2020, 25:42; provided in the office action mailed 29 Sep 2025), cited for evidentiary purposes (see pgs. 3-14, Section 3). This tautomer exists in equilibrium and thus Ring G may alternatively appear at the 3 or the 5 position of the pyrazole ring.
Pyrazole Tautomer I
Pyrazole Tautomer II
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Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 7-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 (in definition of A1), 7 (between subsection (iii) and (iv)), and 8 (in definition of A1) contain Markush groupings which do not have the coordinating conjunctions “and” or “or”, or have the wrong coordinating conjunction to properly limit the alternatives defined in the list. See MPEP § 2117(I). Applicant may overcome this rejection by adding the proper coordinating conjunction to each Markush group in need of one.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 3-4 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ‘128.
The instant claims are directed to the following generic Formula (I):
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‘128 teaches Compound 178 (pg. 33):
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which anticipates claims 1-4 when the instant Ring G is
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; R1 is C1 alkyl; R5 is H; A is C(O)A1; A1 is piperdinyl substituted with one R3a; R3a is C4 hydroxyalkyl; p is 1; and R2 is halo.
Regarding claims 10 and 13, ‘128 teaches a pharmaceutical composition of the reference compounds and a pharmaceutically acceptable carrier (pg. 11) and so anticipates the instant claims 10 and 13.
Allowable Subject Matter
Claims 9 and 18 are allowed. There is no prior art which teaches or suggests any of the compounds found in claim 9 or the compositions in claim 18.
Conclusion
Claims 9 and 18 are allowed. Claims 3-4, 7-8, 10, and 13 are rejected.
Claims 5-6 and 14-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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